Model Number 429688 |
Device Problems
Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/19/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that during the implant procedure, the left ventricular (lv) leads were chosen to be fixed to lateral vein and anterior lateral vein according to vessel angiography.During the procedure, the leads dislodged twice while the sheath was slitting and none of the three leads could be fixed to target position.It was noted that one of the lv leads was used after the use-before-date(ubd).Finally physician replaced with different model lead and fixed it to posterior lateral vein, parameters were satisfactory and the procedure was completed successfully.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned, analyzed and analysis was performed and no anomalies were found.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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